Labegron Extended-Release Tablets 50 mg (Mirabegron)

Adult dose

Adults (including elderly patients): The recommended dose is 50mg orally once daily. This medicine may be taken with or without food. Swallow it with water; do not chew or crush it. The following table shows the recommended daily doses for patients with renal or hepatic impairment, with or without strong CYP3A inhibitors (see “Precautions for Use, 5) Drug Interactions”). Mild renal impairment(1): inhibitor absent 50 mg, inhibitor present 25 mg Moderate renal impairment(1): inhibitor absent 50 mg, inhibitor present 25 mg Severe renal impairment(1): inhibitor absent 25 mg, inhibitor present Not recommended Mild hepatic impairment(2): inhibitor absent 50 mg, inhibitor present 25 mg Moderate hepatic impairment(2): inhibitor absent 25 mg, inhibitor present Not recommended (1) Mild: GFR 60~89 mL/min/1.73m2; moderate: GFR 30~59 mL/min/1.73m2; severe: GFR 15~29 mL/min/1.73m2. (2) Mild: Child-Pugh Class A; moderate: Child-Pugh Class B. (3) For strong CYP3A inhibitors, see “5) Drug Interactions”.

This medication should not be used by patients who are allergic to the active ingredient or any other components. Also, it is recommended that patients with very high blood pressure or severe heart disease avoid this medication. Patients with heart problems that prolong the QT interval or those taking medications that can prolong the QT interval should exercise special caution when using this medication. This medication is not recommended for patients with end-stage renal disease or severe liver dysfunction. Caution is especially needed for patients with impaired kidney or liver function who are taking strong CYP3A4 enzyme inhibitors. Patients with bladder outlet obstruction or those taking antimuscarinic agents for overactive bladder should also be cautious when using this medication. This product contains certain dyes; therefore, individuals with allergies to these ingredients should take care. In clinical trials, some patients who took this medication experienced side effects such as palpitations and urinary tract infections, and rare cases of atrial fibrillation were also reported. In Asian patients, dry mouth was a common side effect, but its occurrence was similar to or lower than that in the placebo group. This medication may raise blood pressure, so patients with hypertension should regularly monitor their blood pressure. Furthermore, it is important for patients undergoing treatment to regularly observe changes in their pulse rate and blood pressure. Patients with bladder outlet obstruction and those taking antimuscarinic agents may experience urinary retention (difficulty urinating), so caution is required. This medication does not significantly affect driving or machine operation abilities, but individual differences may apply, so care should be taken. This drug can interact with several other medications, especially those related to CYP3A4 and CYP2D6 enzymes; therefore, it is advisable to consult with a physician or pharmacist if taking such drugs. Women who are pregnant or may become pregnant should ideally not take this medication, and breastfeeding women should also avoid using this drug. The safety and effectiveness in pediatric patients under 19 years of age have not yet been established. An overdose may result in increased heart rate and blood pressure; hence immediate medical assistance should be sought if an overdose is suspected. When storing this medication, keep it out of the reach of children and store it in its original container to maintain quality.

• Tachycardia
• urinary tract infection
• atrial fibrillation
• increased blood pressure
• dyspepsia
• gastritis
• lip swelling
• urticaria
• rash
• maculopapular rash

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. Storing it this way will help preserve the medication's effects for a longer duration.

Appearance

Yellow oval film-coated extended-release tablet

Package unit

90 tablets/box [10 tablets/PTP x 9]